Home / Import refusals / 9ES-0044824-9/11/1

FDA Import Refusal 9ES-0044824-9/11/1 — Lupin Limited

Lupin Limited — FEI 3007549629

The FDA refused shipment 9ES-0044824-9/11/1 from Lupin Limited (India) on March 13, 2019. The refused product falls under Drugs and Biologics — BUDESONIDE (ANTI-ASTHMATIC). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
March 13, 2019
Country
India
Product Category
Drugs and Biologics
Product Code
61EDQ04 BUDESONIDE (ANTI-ASTHMATIC)
Charges
75

Recent inspections

  • 1079307 (OAI Fri Jan 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1012540 (OAI Fri May 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 911036 (OAI Fri Jan 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 789247 (NAI Fri Jun 22 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 636980 (VAI Wed Nov 18 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • AEK-5916344-2/11/1 (Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-4906989-9/41/1 (Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7029084-7/11/7 (Tue Oct 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-3661110-9/31/1 (Mon Jul 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7725460-5/31/1 (Fri Mar 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources